Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2914-2020·Announced 2020-09-09

Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect could cause holes and tears at the cuffs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible health consequences. The defect involves structural integrity (holes/tears) which compromises the barrier function, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves, Size 6.5. The recall involves approximately 7,119,625 units distributed nationwide in the United States. The product is a disposable surgical glove made of natural rubber latex or synthetic rubber intended for barrier protection in operating rooms.

The recall was initiated because a degradation defect was identified that could lead to holes and donning tears at the folding area around the cuffs. This defect may compromise the integrity of the glove during use.

Healthcare facilities and consumers who have these specific gloves should stop using them and contact Cardinal Health 200, LLC for further instructions or a refund. The recall covers specific lot numbers listed in the official FDA notice, including lots from 2019 and 2020.

The recalled product

Product: PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Gloves
Hazard: structural-defect
barrier-failure
Affected units: 7,119,625

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Item Code: 2D72NT65X Lot #: TS19060064
TS19060158
TS19060303
TS19060393
TS19070019
TS19070068
TS19070138
TS19070185
TS19070297
TS19080022
TS19080051
TS19080128
TS19080134
TS19080239
TS19080326
TS19090058
TS19090104
TS19090212
TS19090295
TS19100043

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · structural defect